Ghana’s Food and Drugs Authority (FDA Ghana) has granted registration to the fixed-dose combination (FDC) of ivermectin and albendazole. With this decision, the innovative medicine—developed by Liconsa and promoted by Mundo Sano together with multiple partners—now has national regulatory approval for clinical use and is no longer restricted to experimental settings.
“This is an important moment and very good news,” said Alejandro Krolewiecki, Director of Innovation at Mundo Sano and leader of the project. “Our goal is to make the co-formulation available to countries, because we believe it will allow them to pursue more ambitious public-health goals.”
The ivermectin–albendazole fixed-dose combination responds directly to the World Health Organization’s call to develop new, more effective medicines (page 160) to help achieve the elimination targets set out in its 2021–2030 Roadmap for Neglected Tropical Diseases.
Drug innovation built on decades of use
Albendazole and ivermectin have been used in public-health programs for decades, but the fixed-dose combination introduces several layers of innovation on top of them.
The medicine comes as a tablet that dissolves on contact with saliva, reducing the risk of choking. It has a mango flavor and introduces a novel age-based dosing strategy for ivermectin, which simplifies both logistics and administration. Compared with single-dose albendazole—the current standard in mass drug administration campaigns—the co-formulation is more effective against a broader range of soil-transmitted helminths, covering all species considered by WHO. It is also easy to integrate into existing programs, as it preserves the “one pill per person” approach.
Administering the two drugs separately requires weighing or measuring each patient and dispensing between two and six tablets. This not only complicates operations but also increases the risk of dosing errors. Relying solely on single-dose albendazole, as most mass deworming programs do, does not adequately control Trichuris trichiura or Strongyloides stercoralis.
A regulatory milestone
Registration of the FDC in Ghana marks a high point in a year, 2025, that began with another major regulatory achievement. In January, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive scientific opinion on the co-formulation under the EU-M4All program, which is designed to guide other regulatory authorities and facilitate processes such as WHO prequalification.
“Registration in Ghana is a major milestone, but we are extremely proud of the entire journey,” said Silvia Gold, President of Mundo Sano and co-founder of Insud Pharma. “This development is an example of a successful public-private partnership, in which public and private actors share risk, knowledge, and commitment. We are deeply grateful to EDCTP and to all the partners who have supported us over the past 15 years.”
The ivermectin–albendazole fixed-dose combination was developed by Liconsa (Insud Pharma) and has its roots in pilot studies supported by Mundo Sano on the prevalence and management of Strongyloides stercoralis in Argentina. Those early efforts highlighted the need for therapeutic tools specifically adapted to public-health programs and to the logistical realities of mass drug administration campaigns.
Next steps: building more evidence
Reaching approval in Ghana has required more than 15 years of work, including research, development, and clinical trials, carried out in collaboration with nearly 20 scientific and health institutions across Latin America, Europe, Africa, and the United States.
Special recognition is due to the European and Developing Countries Clinical Trials Partnership (EDCTP), with whom Mundo Sano signed a collaboration agreement in 2017 to advance research on neglected tropical diseases, as well as its most recent iteration, Global Health EDCTP3 Joint Undertaking. Under their auspices, the STOP consortium was formed and conducted the essential clinical evaluations that led to authorization by the Ghana FDA.
At the same time, clinical research on the ivermectin–albendazole fixed-dose combination continues. The STOP2030 project, co-funded by Global Health EDCTP3 and involving both Mundo Sano and Liconsa, is currently conducting the REALISE study. This clinical trial is assessing the safety of the drug in mass drug administration settings and comparing it with single-dose albendazole in approximately 20,000 school-aged children (5 to 17 years old) in Kenya and Ghana.